Before the implementation of Implementing Regulation (EU) 2025/1466, Marketing Authorisation Holders (MAHs) were required to continuously monitor the EudraVigilance (EV) database and promptly notify authorities of any validated safety signals. Initially, this obligation applied only to a limited number of active substances and combinations during a pilot phase that began in February 2018. During this phase, only MAHs with products on the "pilot list" (which contained a limited number of active substances and combinations of active substances) were obligated to perform signal detection in the EV database.

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With the adoption of Implementing Regulation (EU) 2025/1466, which amends Implementing Regulation (EU) No 520/2012, the pilot phase has officially ended.

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To provide additional clarification to MAHs regarding the termination of the signal detection pilot in EudraVigilance, EMA has published the document Questions and Answers on Implementing Regulation (EU) 2025/1466: Amendment of Regulation (EU) No 520/2012 and Conclusion of the Signal Detection in EudraVigilance Pilot by MAHs.

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These two regulatory documents clarified that, from 12/Aug/2025, all MAHs with medicinal products authorised in the EEA are required to monitor EV data and use it as an additional source of safety information, integrating it with other data sources to support their internal signal management processes.

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Furthermore, MAHs are no longer expected to submit validated signals to the EMA and National Competent Authorities (NCAs) via the standalone notification form. Instead, signals must be managed according to each MAH’s internal processes, following the guidelines in Good Pharmacovigilance Practices (GVP) IX. An update to this GVP module is also scheduled for Q1 2026 to align with forthcoming requirements.

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In conclusion, by streamlining requirements and integrating EV data into MAHs’ internal processes, this update reduces duplication of effort, fostering a more efficient, harmonised, and patient-focused approach to safety surveillance in the EU.

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‍Bullet points:

• ‍‍EV data monitoring is mandatory (not just recommended)
• Applies to all MAHs with products authorised in the EEA
• EV data to be used as an additional source of safety information
• No more standalone signal forms
• Changes to be implemented by MAHs by 12/Aug/2025
• GVP IX update scheduled to Q1 2026

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